MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE PLATFORM RESUSCITATION; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/18/2020

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of "when the autopulse platform (sn: (b)(4)) was powered on, the platform failed to perform compressions and displayed the prompt, 'pull up lifeband and press restart'" was confirmed based on the archive data review and during the functional testing.The archive showed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large), ua18 (max take-up revolution exceeded), and ua02 (compression tracking error) error messages to have occurred on the customer's reported complaint date.The error messages could not be replicated during the initial functional testing.However, further investigation findings revealed that the root cause for all the above-mentioned user advisories was due to the defective (over-reported) load cell module 1, likely attributed to a defective component or harsh impact due to user handling.Upon visual inspection, no physical damage was observed on the returned autopulse platform.A review of the autopulse platform archive was performed, and it showed that on the reported event date, the autopulse was powered on with a duration of 7 seconds with no compressions performed; thus, confirming the reported complaint.Then, the platform displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message.The user managed to clear the error and re-started the platform, but the same issue happened several more times.Later, after the autopulse was re-started, the platform displayed ua18 (max take-up revolution exceeded) error message.The user re-started the platform and cleared the error message.However, the platform was powered back on with ua07.Based on the archive, the platform was repeatedly re-started several more times, and each time, the device was powered back on with either ua07 or ua18.The archive shows that eventually, the autopulse performed a total of two compressions, and then, the platform displayed ua02 (compression tracking error) error message, which was cleared by the user.The platform was powered back on with ua18 once more, and then, the use of the autopulse platform was discontinued.The autopulse platform passed the initial functional test without any fault or error.However, during power-on-self-test, the load sensing system detected a weight or load imbalance between the two load cells.The load cell characterization test was performed and indicated that load cell module 1 value was over reported, which caused the user advisories ua07, ua18, and ua02 to occur intermittently on the reported event date.The defective load cell module 1 will be replaced to remedy the fault.During further functional testing, it was noted that the encoder driveshaft could not rotate smoothly, exhibiting binding and resistance, unrelated to the reported complaint.The root cause for this issue is most likely due to sticky driveshaft clutch area, which is usually caused by sharp edges from all 12-hex edges of the armature plate or due to burrs on the surface of the clutch rotor, likely attributed to normal wear and tear.The sticky clutch plate will be deburred to address the issue.Awaiting customer's approval for repair.Historical complaints were reviewed for service information related to the reported complaint, and there was no similar complaint reported for autopulse with serial number (b)(4).

Event Description

During patient use, when the autopulse platform (sn: (b)(4)) was powered on, the platform failed to perform compressions and displayed the prompt, "pull up lifeband and press restart." the user pressed the green start/continue button to start chest compressions, but the attempt was unsuccessful.With the patient on the platform, the lifeband was disconnected and re-installed, and the autopulse was powered back on.However, the same prompt was displayed again.The user checked the lifeband and the patient's position and re-started the autopulse, but the issue was not resolved.To troubleshoot, a new lifeband was installed with no success.Patient's status information was requested, but the customer did not provide a response; therefore, patient's status is unknown.

Manufacturer Narrative

B5: event description was updated with additional information received.

Event Description

During patient use, when the autopulse platform (sn: (b)(4) was powered on, the platform failed to perform compressions and displayed the prompt, "pull up lifeband and press restart." the user pressed the green start/continue button to start chest compressions, but the attempt was unsuccessful.With the patient on the platform, the lifeband was disconnected and re-installed, and the autopulse was powered back on.However, the same prompt was displayed again.The user checked the lifeband and the patient's position and re-started the autopulse, but the issue was not resolved.To troubleshoot, a new lifeband was installed with no success.No consequences or impact to patient.

• Brand Name: AUTOPULSE PLATFORM RESUSCITATION
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• MDR Report Key: 10165889
• MDR Text Key: 196297766
• Report Number: 3010617000-2020-00615
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001038
• UDI-Public: 00849111001038
• Combination Product (y/n): N
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0740-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2020
• Date Manufacturer Received: 06/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1